FDA clears two K2M 3D-printed Cascadia devices

1st June 2016

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K2M has received 510(k) clearances from the US Food and Drug Administration (FDA) to market its Cascadia cervical and the Cascadia AN lordotic oblique interbody systems featuring Lamellar 3D titanium technology. This is intended to allow for bony integration throughout the implant.

“I’m excited to have the Lamellar 3D titanium technology available for the cervical spine as it presents a balance of roughness and porosity that allows the potential for bone to grow into the implant,” says Tom Morrison, a neurosurgeon at Polaris Spine & Neurosurgery Center in Atlanta, USA, who completed the first surgical case using Cascadia cervical interbody system. “Additionally, the biomechanical stiffness of the Cascadia implants are similar to PEEK and less than a more-traditional solid titanium design.”

K2M’s Lamellar 3D titanium technology uses a 3D-printing method to create structures that it claims were once considered impractical with traditional manufacturing techniques. Starting with a titanium powder, Casacadia implants are grown through the selective application of a high-energy laser beam, allowing for the incorporation of both a porosity and surface roughness that preclinical data have associated with bone growth activity, according to a company release.

The Cascadia cervical interbody system is designed to function as an intervertebral body fusion device to provide support and stabilisation of the cervical segment of the spine for patients suffering from degenerative spinal disorders. The Cascadia AN lordotic oblique interbody system is intended to provide surgeons with a full range of anatomically-designed interbodies for oblique placement through a transforaminal-lumbar approach. All Cascadia interbody systems are cleared for use with both autologous and allogenic bone graft tissue in the treatment of patients with degenerative disc disease and degenerative scoliosis.

In conjunction with the two regulatory clearances, K2M also received clearance to market additional offerings of the Cascadia TL and Cascadia cervical interbody systems. The complete Cascadia portfolio also includes the Cascadia lateral and AN interbody systems, both of which received 510(k) clearance from the FDA within the past year.